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New Analysis Published in Nature Medicine Demonstrates Advantages of Nationwide Coronary CTA Strategy with Heartflow FFRCT in Over 90,000 Patients with Coronary Artery Disease

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Two-year data from England’s National Health Service show improved care efficiency with reduction in unnecessary invasive and noninvasive cardiac tests using CCTA and Heartflow FFRCT versus CCTA aloneMOUNTAIN VIEW, Calif., May 06, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc., the leader in AI technology for coronary artery disease (CAD), today announced two-year data from FISH&CHIPS, a real-world, multicenter, retrospective study, conducted by the National Health Service (NHS) in England, were published in Nature Medicine. The study, which analyzed the impact of adding Heartflow fractional flow reserve (FFRCT) derived from coronary computed tomography angiography (CCTA) to a CCTA pathway for the evaluation of CAD, showed improved care efficiency and reduction in unnecessary tests with CCTA+FFRCT versus CCTA alone. “New findings from the FISH&CHIPS study demonstrate that a CCTA+FFRCT pathway at a national level can positively impact individual patient care, improving the suspected coronary artery disease patient’s journey,” said Dr. Timothy Fairbairn, principal investigator for the study, Liverpool Heart and Chest Hospital NHS Foundation Trust, and associate professor at the University of Liverpool, U.K. “FFRCT is a major AI-driven advancement in the management of cardiac disease that is helping to ensure that patients receive more precise, improved care, by reducing unnecessary invasive procedures and additional tests whilst identifying those who need intervention.” The overarching results of the more than 90,000-patient study, covering the breadth of NHS England, showcased the positive impact of a CCTA+FFRCT diagnostic pathway using Heartflow technology versus CCTA alone. Key outcomes outlined in the published data include: The CCTA+FFRCT cohort reduced the need for an invasive coronary angiography (ICA) procedure by 7% and led to a reduction in inappropriate ICA procedures that did not result in treatment by 16%.CCTA+FFRCT helped to identify more patients that would benefit from revascularization, with one additional appropriate percutaneous coronary intervention (PCI) identified for every two negative diagnostic catheterizations that were avoided.CCTA+FFRCT showed a 12% relative reduction in the need for a secondary non-invasive test after CCTA, for example requiring a repeat CCTA or nuclear stress test. “By implementing a nationwide CCTA-first strategy for assessing patients with potential cardiovascular disease, NHS has set the standard for both clinical efficacy and efficiency — an approach now reflected in clinical guidelines worldwide,” said Campbell Rogers, M.D., FACC, Heartflow’s chief medical officer. “The FISH&CHIPS data underscore how the addition of Heartflow’s FFRCT technology can improve upon the CCTA-first approach for many patients and optimize the use of both noninvasive testing and treatment.” Heartflow is the only company to offer a complete non-invasive, precision coronary care platform designed to manage CAD for life. With Heartflow One, a CCTA scan is transformed into a dynamic and personalized 3D model of the heart. Within the platform, Heartflow FFRCT provides lesion-specific physiology, enhancing CCTA’s diagnostic accuracy and helping determine whether there is benefit to revascularization. Heartflow Plaque Analysis leverages AI to quantify and characterize the amount and type of plaque in the coronary arteries to determine appropriate medical management. These advancements provide physicians with more precise, personalized insights into heart health, aiding in treatment planning and identifying individuals at high risk of major adverse cardiovascular events (MACE), such as heart attacks, which can occur in patients with or without symptoms of CAD. Heartflow is dedicated to transforming CAD from the leading cause of death to a disease that can be proactively managed for life by partnering with physicians and institutions to generate robust, high-quality clinical evidence. Heartflow has been adopted by more than 1,400 institutions globally. About FISH&CHIPSFISH&CHIPS is a real-world, multicenter, quasi-experimental observational clinical study designed to assess the incremental impact of adding FFRCT to a CCTA-first diagnostic paradigm for CAD at a national level. The study analyzed data from 27 NHS hospital sites in England, including 90,553 patients followed for at least two years. The primary objective was to determine whether introducing a CCTA+FFRCT diagnostic pathway was clinically useful and safe compared to a standard-of-care CCTA diagnostic chest pain pathway. The study was funded by the UK Medical Research Council (MRC) and supported by the National Institute for Health and Care Research (NIHR) Research Delivery Network. About Heartflow, Inc.Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform — including RoadMap™ Analysis, FFRCT Analysis and Plaque Analysis — is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at www.heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com

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Saddleback Medical Center Expands Cardiac Surgical Capabilities With Recruitment of Renowned Cardiothoracic Surgeons

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Asad Shah, M.D. and Timothy Lee, M.D., two nationally esteemed cardiothoracic surgeons join the MemorialCare Heart & Vascular Institute to bring advanced robotic cardiac surgery capabilities to the South Orange County community, helping to fill a gap in care LAGUNA HILLS, Calif., May 5,…

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Primary Care Physician Use of Counterpart Assistant Technology Associated with Better Health Outcomes in Patients with Congestive Heart Failure

Coronary/Structural Heart by Comments are Disabled

New whitepaper highlights how a relationship with a Primary Care Physician (“PCP”) that uses Counterpart Assistant is associated with better clinical management, and fewer hospitalizations (18% lower) and readmissions (25% lower) in heart failure patients New whitepaper highlights how a relationship with a Primary Care Physician (“PCP”) that uses Counterpart Assistant is associated with better clinical management, and fewer hospitalizations (18% lower) and readmissions (25% lower) in heart failure patients

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Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic Cardiomyopathy

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SOUTH SAN FRANCISCO, Calif., May 01, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26, 2025. The FDA recently notified Cytokinetics that additional time is required to conduct a full review of the company’s proposed Risk Evaluation and Mitigation Strategy (REMS). Following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in oHCM without an accompanying REMS, and the FDA accepted the NDA for filing. Recently, during the NDA review, the FDA requested that Cytokinetics submit a REMS, based on the inherent characteristics of aficamten, which the company provided. The submission of a REMS has now been determined by FDA to be a Major Amendment to the NDA resulting in a standard three-month extension to the original PDUFA action date. No additional clinical data or studies have been requested of Cytokinetics by FDA. “We remain confident in the distinct benefit-risk and pharmaceutic profile of aficamten and continue to expect a differentiated label and risk mitigation profile upon its potential approval by FDA,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We look forward to continuing our constructive engagement with the FDA regarding the NDA for aficamten.” About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization of aficamten in the United States or any other jurisdiction by the target PDUFA date or any other date, if ever, and statements regarding our expectation that aficamten will be approved with a differentiated label and REMS. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including FDA’s on-going review of our NDA for aficamten in obstructive hypertrophic cardiomyopathy. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757

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Elutia Transitions to Direct Distribution of Its Cardiovascular Product Portfolio

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Move expected to drive both top-line growth and gross margin improvement SILVER SPRING, Md., May 01, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today announced it is reclaiming U.S. sales and distribution responsibilities for its cardiovascular portfolio—including ProxiCor®, VasCure®, and Tyke®—following the conclusion of its distribution agreement with LeMaitre Vascular, Inc. The move allows Elutia to directly capture top-line revenue and should improve the gross margin and profitability of this product segment. Elutia has appointed Dwayne Montgomery as Head of Cardiovascular to lead this newly established business unit. A seasoned commercial executive, Mr. Montgomery brings proven senior leadership experience from Osiris Therapeutics, Smith & Nephew, Guidant, and C.R. Bard. Under Mr. Montgomery’s leadership, Elutia has recruited and mobilized a high-performing team of 26 independent (1099) sales representatives specifically for the cardiovascular line. Operating independently from the EluPro™ commercial organization, this focused structure allows both commercial teams to stay laser-focused on their respective missions. With training of the cardiovascular team now complete, Elutia has commenced direct sales as part of a coordinated transition of accounts from LeMaitre, ensuring continuity and minimizing disruption for customers. “While we’re grateful for our partnership with LeMaitre, bringing this asset back in-house allows us to fully unlock its value,” said Dr. Randy Mills, CEO of Elutia. “Direct control over sales to the end user allows us to sharpen our execution, drive top-line growth, improve profitability and cash flow, and gives us greater strategic flexibility. Under Dwayne’s leadership, the team has already made impressive progress—and we’re just getting started.” Elutia’s cardiovascular portfolio is expected to deliver approximately 80% gross margins and maintain a premium price position in the market. The Company also expects growth at the top-line. In 2024, sales of cardiovascular products accounted for $2.9 million, or about 12%, of total revenue. Unlike synthetic grafts, these regenerative biomatrix products promote a healthy immune response and avoid the typical foreign body reaction associated with synthetics. The portfolio includes: ProxiCor® PC, for pericardial closure; ProxiCor® CTR, for cardiac tissue repair; Tyke®, the only extracellular matrix cleared for neonatal and infant patch, pledget, and intracardiac repair; and VasCure®, for vascular repair. About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. Forward-looking statements contained in this press release include, without limitation, any statements we make regarding: improving future results of our cardiovascular portfolio by assuming sales responsibility for it, including any predictions as to future revenues, pricing or gross margins of our cardiovascular products; the timing of commencement of sales through our independent sales force; and the efficiency of the transition. . These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our ability to successfully commercialize, market and sell our products; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com This press release was published by a CLEAR® Verified individual.

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BioCardia Announces First Patient in Phase 3 Randomized Controlled Double-Blind CardiAMP HF II Clinical Trial of the Company’s Lead Cell Therapy for Treatment of Heart Failure

Coronary/Structural Heart by Comments are Disabled

SUNNYVALE, Calif., May 01, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the first patient enrolled in the Phase III randomized procedure placebo-controlled double-blind CardiAMP HF II clinical trial of the Company’s lead autologous cell therapy program for the treatment of heart failure at BayCare Morton Plant Hospital in Clearwater, Florida. “We are excited to lead enrollment in the CardiAMP HF II trial and be able to offer this cell therapy study to our heart failure patients. This investigational therapy has been shown to enhance microvascular function and demonstrated promising clinical outcomes in the recently completed CardiAMP HF Trial, particularly for the patients we are targeting for this trial,” said Dr. Leslie Miller, M.D., Chief of the Congestive Heart Failure and Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida. Dr. Miller is also a CardiAMP HF II Trial Principal Investigator and member of the Executive Steering Committee. “The unique ability to personalize this treatment based on a patient’s own cellular characteristics make CardiAMP cell therapy attractive for treating heart failure. The approach preserves all therapeutic options for our patients, including repeated cell therapy, and avoids the need for immune suppression. I congratulate and thank our team at Morton Plant Hospital for achieving this important milestone in enrolling the first patient in the world’s first confirmatory Phase 3 cardiac cell therapy trial for heart failure.” “Our first CardiAMP HF II study procedure went smoothly and per protocol,” said Dr. Rakesh Sharma, M.D., Interventional Cardiologist at BayCare Morton Plant Hospital in Clearwater, and CardiAMP HF II investigator. “Our efforts in cardiac cell therapy over many years have supported the potential of this CardiAMP cell therapy where cells are harvested, processed, and delivered into the heart muscle by our research team. I value the Helix minimally invasive cell intramyocardial delivery platform for its ability to enable targeting of specific segments in the heart with confidence and find the new Morph DNA steerable navigation catheter to be an elegant enhancement.”   “We are thankful for the BayCare Morton Plant team led by Dr. Miller and Dr. Sharma as well as the many other world-class clinical teams engaged in the CardiAMP cell therapy trials,” said Peter Altman, PhD, BioCardia President and Chief Executive Officer. “We are preparing regulatory submissions in Japan and the USA intended to seek separate approvals of the CardiAMP cell therapy and Helix biotherapeutic delivery platform based on our existing TABMMI1, TAC-HFT2,3, and CardiAMP HF4 clinical data. The CardiAMP HF II trial is intended to collect confirmatory evidence to support this autologous cell therapy with respect to approvals, adoption, and reimbursement.” About the CardiAMP Heart Failure II Study CardiAMP HF II is a 250-patient randomized multicenter procedure placebo-controlled study of the CardiAMP autologous cell therapy as a one-time treatment for patients with ischemic heart failure with reduced ejection fraction (HFrEF) on guideline directed medical therapy having elevated NTproBNP.   The study is intended to confirm the safety and efficacy results in these patients observed in the CardiAMP HF study4. The CardiAMP HF II study uses a similar three-tier composite primary outcome measure to CardiAMP HF, with tier 1 all cause death, tier 2 nonfatal major adverse cardiac events, but with tier 3 using a validated quality of life patient self-assessment instrument. In CardiAMP HF, this composite efficacy endpoint was achieved with statistical significance in the patients with elevated NTproBNP that are the focus of the CardiAMP HF II study (p=0.02).  Advances in this therapeutic approach in CardiAMP HF II include using the cell population analysis at screening to define treatment doses, which enables more patients to be eligible for the therapy, and improvements to the Helix system, which include the introduction of the FDA approved Morph DNA steerable platform.   About CardiAMP Autologous Cell Therapy Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response to increase capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The mechanisms that lead to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial autonomic dysfunction, are all targets of CardiAMP cell therapy, largely through production of growth factors, cytokines, chemokines, and other factors that directly counteract each of these mechanisms. The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS).  CAUTION – Limited by United States law to investigational use.  About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms.  For more information visit: www.BioCardia.com. Forward Looking Statements  This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to our investigational product candidates, the potential benefits and mechanism of actions of the CardiAMP cell therapy, future regulatory approvals, enrollment in our clinical trials, and the safety and efficacy of our product candidates and therapies. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.  We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.   References: de la Fuente LM, Stertzer SH, Argentieri J, et al. Transendocardial autologous bone marrow in myocardial infarction induced heart failure, two-year follow-up in an open-label phase I safety study (the TABMMI study). EuroIntervention. 2011 Nov;7(7):805-12.Heldman AW, DiFede DL, Fishman JE, et al. Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial. JAMA. 2014 Jan 1;311(1):62-73.Wong Po Foo et al., The transendocardial autologous cells in ischemic heart failure trial bone marrow mononuclear cells (TAC-HFT-BMC) randomized placebo controlled blinded study, Regenerative Medicine 2015, 10(7s), S169.Raval A, on behalf of the CardiAMP HF Investigators. A Double-blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF: Principal Results from the CardiAMP-HF Trial, American College of Cardiology Scientific Sessions, March 30, 2025. Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120

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New Study Reports Increased 4-Year Survival in Heart Transplant Patients when Utilizing the Paragonix SherpaPak System

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Data from the GUARDIAN Registry, presented at the 45th ISHLT Annual Meeting, shows the Paragonix SherpaPak ® Cardiac Transport System led to statistically significant improvements in short and long-term post-transplant survival and cardiac complications WALTHAM, MA. April 29, 2025 – Paragonix Technologies ,  a leader in organ transplant technologies and […]

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CareDx Announces New Data on AlloSure Lung Presented at 2025 International Society for Heart and Lung Transplantation Meeting

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Findings from ALAMO Study Show AlloSure Lung is Associated with Prognosis of Chronic Lung Allograft Dysfunction and Restrictive Allograft Syndrome AlloSure Lung Surveillance Monitoring Identifies the Onset of Acute Cellular Rejection and Treatment Response BRISBANE, Calif.–(BUSINESS WIRE)–CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company […]

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Orchestra BioMed Receives FDA Approval of IDE to Initiate U.S. Coronary Pivotal Trial Randomizing First-in-Class Sirolimus-AngioInfusion Balloon, Virtue SAB, Head-to-Head with Paclitaxel-Coated Balloon

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Orchestra BioMed’s Virtue® Sirolimus AngioInfusion Balloon™ (“Virtue SAB”) is the only non-coated drug-eluting balloon system under clinical investigation worldwide and has been awarded multiple FDA Breakthrough Device DesignationsThe Virtue Trial will be the first U.S. IDE head-to-head randomized evaluation of a sirolimus-eluting balloon versus a commercially available paclitaxel-coated balloon (AGENT™) for the treatment of coronary in-stent restenosis (“ISR”)Robust non-inferiority trial is designed to provide a clear pathway to regulatory approval as well as potentially showcase clinical advantages of Virtue SABWith the amended IDE approved by the FDA, Orchestra BioMed is currently targeting initiation of the Virtue Trial during the second half of 2025 NEW HOPE, Pa., April 29, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that the U.S. Food and Drug Administration (“FDA”) has approved its Investigational Device Exemption (“IDE”) amendment to initiate an updated design of the Company’s planned Virtue SAB in the Treatment of Coronary ISR Trial (“Virtue Trial”). The IDE provides FDA regulatory clearance for Orchestra BioMed to initiate a U.S. pivotal clinical trial comparing its highly differentiated, next-generation Sirolimus-AngioInfusion Balloon, Virtue SAB to the Boston Scientific AGENT paclitaxel-coated balloon, currently the only drug-coated balloon (“DCB”) FDA-approved for a coronary indication. Data from the Virtue Trial will be used to support regulatory approval in the U.S. Virtue SAB and SirolimusEFR are investigational technologies owned by Orchestra BioMed, which also controls and is responsible for all regulatory filings, clinical operations, and drug and device supplies for the Virtue Trial. The Differentiation of Virtue SAB, An FDA Breakthrough Designated DeviceVirtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit to consistently deliver a large liquid dose, overcoming certain limitations of DCBs. SirolimusEFR™ enables tissue uptake and extended release of the required therapeutic levels of sirolimus ( > 1ng/mg tissue concentration), the “gold-standard” drug for preventing arterial restenosis, through the critical healing period of approximately 30 days.​ Virtue SAB has been previously granted FDA Breakthrough Device Designation for the treatment of coronary ISR as well as for coronary small vessel disease and peripheral artery disease below-the-knee. In the multi-center SABRE pilot study, Virtue SAB demonstrated best-in-class clinical results for the treatment of coronary ISR, including 12-month target lesion failure of 2.8% and 6-month late lumen loss of 0.12mm. “Virtue SAB has the potential to be one of the most compelling technologies in interventional cardiology. It’s the only product in development that optimizes both the arterial tissue uptake and retention of sirolimus to achieve pharmacokinetics that match or even exceed those of proven ‘limus-eluting stents,” said Dean J. Kereiakes, M.D., FACC, MSCAI, Chairman of The Christ Hospital Heart & Vascular Institute, Medical Director of The Christ Hospital Research Institute, Professor of Clinical Medicine at The Ohio State University, Professor of Medicine at University of Cincinnati and Co-Principal Investigator on the Virtue Trial. Dr. Kereiakes continued: “Virtue SAB is designed to consistently deliver a large liquid dose of an extended-release formulation of sirolimus to overcome certain limitations of traditional DCBs, including lower doses due to surface area and coating integrity constraints, drug loss in transit leading to inconsistent dosing, and the risk of emboli from large coating particulates. As the coronary treatment landscape continues to shift toward more rapid adoption of DCBs, I’m excited about the potential of Virtue SAB to set a new standard of care.” “Drug-coated balloons are emerging as a new standard of care in the treatment of various coronary and peripheral indications, and I believe utilization of this class of technology will continue to grow and evolve over time as the science is expanding. In a field largely reliant on paclitaxel drug-coated balloons, Virtue SAB stands out as the only device with a completely different mechanism of action; namely to provide delivery of a large liquid dose of an extended-release formulation sirolimus,” commented Allen Jeremias, MD, MSc, Associate Director of the Cardiac Catheterization Laboratory at St. Francis Hospital & Heart Center, and Co-Principal Investigator on the Virtue Trial. “Having had the opportunity to work with several DCBs, I anticipate continued momentum for this class, and am eager to see how Virtue SAB, particularly with its anti-restenotic, anti-inflammatory and cytostatic SirolimusEFR formulation, performs in a head-to-head trial against a paclitaxel-coated balloon.” Showcasing Distinctive and Sustainable Advantages of Virtue SAB Through a Head-to-Head Trial “We believe there is a multibillion-dollar U.S. market for coronary drug delivery balloons based on the significant unmet clinical need, market demand, and established reimbursement,” said David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed. “We made a deliberate, strategic decision to pursue a head-to-head trial with the commercially available AGENT paclitaxel-coated balloon, underscoring our confidence in Virtue SAB as a fundamentally differentiated solution for the treatment of atherosclerosis. We believe this approach offers the most direct path to regulatory approval while also providing the best opportunity to demonstrate what we believe are distinctive and sustainable advantages of our proprietary technology.” Mr. Hochman continued, “The superior safety and efficacy of sirolimus over paclitaxel was made clear by the performance of drug-eluting stents. Published meta-analysis involving 76 trials show ‘limus-eluting stents have significantly better clinical performance than paclitaxel-eluting stents in terms of target lesion revascularization and major adverse cardiac events.1 We believe this is due to their ability to maintain sufficient drug tissue concentration through the critical healing period of approximately 30 days, because stents that failed to do this did not perform well clinically.2,3,4 Virtue SAB is the only drug delivery balloon that has demonstrated comparable drug tissue levels to clinically successful drug-eluting stents in large published preclinical studies, without the need to leave a permanent metal implant in the artery. Our pilot clinical results with Virtue SAB also highlight the potential for optimal clinical outcomes with robust sirolimus delivery. We’re excited to showcase the full potential of Virtue SAB in this landmark trial and are proud of our team and grateful to our clinical collaborators for their work in achieving this important milestone.” The Virtue Trial is a prospective, multi-center, randomized trial comparing clinical outcomes of Virtue SAB to AGENT Paclitaxel DCB in the treatment of coronary ISR, a difficult-to-treat and serious complication of coronary stenting. The primary endpoint is a non-inferiority comparison of Target Lesion Failure (TLF) defined as a composite of cardiac death, nonfatal target vessel myocardial infarction and ischemia-driven target lesion revascularization at 12 months. The trial will randomize 740 patients across up to 75 centers in the U.S. With the amended IDE approved by the FDA, Orchestra BioMed is currently targeting initiation of the Virtue Trial during the second half of 2025, bringing the Company one step closer to delivering a next-generation solution for atherosclerotic disease. About Coronary In-Stent Restenosis (ISR)Coronary ISR is a serious complication of coronary stenting, which can increase the risk of life-threatening heart problems. It is characterized by a re-narrowing of a coronary artery segment that was previously treated with a stent. According to the National Cardiovascular Data Registry, coronary ISR occurs in up to 10% of stented patients during the first year and continues at a rate of up to 3% per year thereafter, resulting in an estimated over 325,000 coronary ISR lesions annually worldwide that may require treatment. If left untreated, coronary ISR may lead to stable angina, unstable angina, acute coronary syndrome, acute myocardial infarction, or death. About Virtue SABVirtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit to consistently deliver a large liquid dose overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. About Orchestra BioMed Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (AVIM) therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. Forward-Looking StatementsCertain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the timing of the initiation and of the Virtue Trial, the number of patients to be enrolled in the Virtue Trial, and the potential safety and efficacy of the Company’s product candidates, including the ability of Virtue SAB to overcome certain limitations of DCBs. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s product candidates; the timing of, and the Company’s ability to achieve, expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s annual report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 31, 2025, as updated by any risk factors disclosed under the heading “Item 1A. Risk Factors” in the Company’s subsequently filed quarterly reports on Form 10-Q. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor ContactJeremy FefferLifeSci AdvisorsJfeffer@lifesciadvisors.com Media ContactKelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com References 1Xinlin Zhang, et. al. PLOS ONE 2014 May 20;9(5):e97934. 2https://slideplayer.com/slide/5787004. 3 Tada, et. Al., Am Heart J. 2013 Jan;165(1):80-6. 4Leon M LBT III, Session 3014 ACC 2011.

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Sensydia Announces First Patient Enrolled in Pivotal Study of Non-Invasive Cardiac Performance System (CPS™)

Coronary/Structural Heart by 0 comments

LOS ANGELES–(BUSINESS WIRE)–Sensydia, a medical technology company pioneering non-invasive cardiac assessment, today announced that the first patient has been enrolled in its multi-center pivotal study to evaluate the accuracy of the Cardiac Performance System (CPS) for hemodynamic assessment as compared to the gold-standard: invasive right heart catheterization. Sensydia’s CPS acquires cardiovascular signals, […]

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